News of Pharmaceuticals | Healthcare | Wellness in Gujarat

Biocon & Mylan to present final overall survival data of biosimilar for cancer

HERTFORDSHIRE (ENGLAND) | PITTSBURGH (US) | BENGALURU | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT  – In a press release submitted to the Exchanges in India on Thursday, Biocon Ltd said of Biocon and Mylan to Present Final Overall Survival Data for Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin4P, at the American Society of Clinical Oncology (ASCO) Annual

USFDA inspection at Alkem’s St. Louis (US) facility concluded with observations, regulators indicate official action

ST. LOUIS (US) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a regulatory filing submitted to the Indian Exchanges, Mumbai headquartered Indian Pharam company Alkem Laboratories Ltd said of the USFDA (US Food & Drugs Administration) concluded inspection at St. Louis (US) facility of the company and that the company will close out all observations

USFDA inspects Lupin Pharma’s Mumbai facility, slam 4 observations

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – USFDA (US Food & Drugs Administration) inspected the Mumbai facility of Lupin Pharma and has issued Establishment Inspection Report to the site & facility inspected.  The Regulators have also slammed 4 observations post inspecting the Lupin’s Mumbai facility In a regulatory filing submitted to the Indian Exchanges,  Pharma major

Zydus Cadila gets USFDA nod to market high blood-pressure treatment drug

AHMEDABAD | MUMBAI | RAJKOT – In a press release submitted to the Stock Exchanges in India on Monday, Ahmedabad headquartered Zydus Cadila Group (Cadila Healthcare) said of having received the final approval from the USFDA (United States Food & Drugs Administration) to market Chlorthalidone Tablets USP (US RLD – THALITONE@),25 mg and 50 mg.

USFDA slams “certain observations” after inspecting Torrent Pharma’s Indrad facility

AHMEDABAD-GANDHINAGAR | MUMBAI | RAJKOT – In a regulatory update filing submitted to the Indian Bourses, Ahmedabad located pharma company  Torrent Pharmaceuticals Ltd said, inspection at Indrad Plant of the Company was carried out by US FDA in the month of April, 2019. The company has received certain observations which are procedural in nature and

Glenmark Pharma gets Russian Health Ministry’s nods to sell Nasal Sprays

MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press release submitted to the Indian Exchanges, Mumbai headquartered Glenmark Pharmaceuticals Ltd., a research‐led, integrated global pharmaceutical company, today announced that it has received approval from the Ministry of Healthcare, Russia to market Momate Rhino (Mometasone Furoate 50 mcg) metered nasal spray as an over‐the‐counter (OTC) product

Alembic Pharma gets USFDA nod to market opthalmic (eye treatment) solution

VADODARA (BARODA) | MUMBAI | AHMEDABAD | GANDHINAGAR | RAJKOT – In a press-release submitted to the Indian Exchanges on Monday, Vadodara headquartered pharma major Alembic Pharmaceuticals Ltd said of US Food & Drugs Administration (USFDA) giving nod to the company to market Bimatoprost Ophthalmic Solution, 0.03%. According to IQVIA estimated market size for the

Wockhardt’s Bioequivalence Centre @ Aurangabad inspected by USFDA, no observations

AURANGABAD | MUMBAI | RAJKOT – In a regulatory update filing submitted to the Indian Bourses on Monday, India Pharma major Wockhardt Ltd said of  US Food and Drug Administration (USFDA) carried out inspection of Bioequivalence Centre located at R&D Centre, Aurangabad during which Bioequivalence studies of Tamsulosin 0.4mg capsules and Metoprolol Tartrate 200mg ER

Zydus Cadila (Healthcare) gets USFDA nod to market anti-epileptic drug to prevent & control seizures

AHMEDABAD-GANDHINAGAR | MUMBAI | RAJKOT – In a press-release submitted to the Indian Bourses on Monday, Ahmedabad headquartered pharma major – Cadila Healthcare Ltd (Dr Pankaj Patel led Zydus Cadila Group) has received the tentative approval from the USFDA to market Lacosamide Tablets (US RLD – Vimpat®) in the strengths of 50 mg, 100 mg,

Sun Pharma Launches Ready-to-Infuse INFUGEM injection for cancer treatment

PRINCETON (NEW JERSEY, US) | VADODARA | MUMBAI | RAJKOT – In a press-release submitted to the Indian Exchanges on Monday, Indian Pharma sector major Sun Pharmaceutical Industries Ltd. today announced that INFUGEM™ (gemcitabine in sodium chloride injection), for intravenous use, is now commercially available in the U.S. INFUGEM, the first chemotherapy product that comes

Cipla’s Goa units gets EIR after being inspected by USFDA

MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, pharma major Cipla Ltd said United States Food and Drug Administration (USFDA) at the Goa manufacturing facility from 21st – 28th January, 2019, the Company has received the Establishment Inspection Report (EIR), indicating closure of the inspection. For more details, please click the

Bal Pharma’s Rudrapur unit gets EUGMP approved

BENGALURU | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses on Wednesday, Bengaluru headquartered Bal Pharma Ltd said of the formulations manufacturing unit of the Company located at Rudrapur, Uttarakhand has received certification for GMP compliance for manufacturing of formulations, as per European Union regulations. This EUGMP approval allows the

SRF’s Dahej plant to resumes ops, was shut vide directives from State Pollution authority

DAHEJ | GURUGRAM | RAJKOT – In a regulatory update statement submitted to the Indian Bourses on Wednesday, Gurugram Headquartered SRF Ltd said of its Dahej plant to resume operations soon, vide the revocation order dated 3″“ April 2019 which has been issued by Gujarat Pollution Control Board (GPCB) and in compliance with the said

USFDA concludes Cadila Healthcare’s (Zydus) Pharmez facility with one observation

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, on Wednesday, Ahmedabad headquartered Pharma major Cadila Healthcare (Dr Pankaj Patel led Zydus Cadila Group) Ltd said of one of their units being inspected by US Food & Drugs Administration (USFDA) and the regulator has concluded the inspection with one

Cadila Healthcare (Zydus) gets USFDA nod to market tabs to cure urniery tract disorders

AHMEDABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, Ahmedabad headquartered Zydus Cadila has received the tentative approval from the USFDA to market Mirabegron Extended-Release Tablets (US RLD- Myrbetriq® Extended-Release Tablets), 25 mg and 50 mg. Mirabegron is selective beta 3-adrenoceptor agonist approved for the treatment of Overactive Bladder

Dr Reddy’s Lab enters into agreement with Celegne to settle legally disputed product suit

HYDERABAD | MUMBAI | RAJKOT – In a regulatory filing submitted to the Indian Bourses, Hyderabad headquartered Dr Reddy’s Laboratories Ltd said of  having entered into a confidential settlement agreement with Celgene (NASDAQ:CELG) for its Abbreviated New Drug Submissions (ANDS) related to a generic version of REVLIMID® brand capsules, (Lenalidomide) pending before Health Canada. For